Full Job Description
The Clinical Lab Project Manager is responsible for program-level oversight of biomarker and clinical laboratory operations within Precision Medicine. The individual provides planning and operational leadership-proactively managing various strategic forums, quality, timelines, vendors, and risk-for the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP, and company Standard Operating Procedures within assigned programs. The role leads strategy, planning, and continuous-improvement efforts for the function and is a member of the Precision Medicine Clinical Laboratory Operations leadership team, interfacing with senior leadership across Global Development.
When & where:
• Work Location: Armonk, NY or Warren, NJ or Remote, USA
• Hybrid: 4 days per week on site
Discover your role:
• Maintain a program-level overview of clinical laboratory status and issues; proactively communicate progress, risks, issues, or changes that may impact quality, timelines, and/or budget, and provide program-level updates to stakeholders as requested.
• Oversee clinical laboratory timelines across the assigned program(s); review plans and provide clinical laboratory operations decision making per the clinical laboratory strategy for early lab engagement, study start-up, and conduct phases, ensuring study starts and data delivery are aligned with decision making.
• Ensure timely delivery of operational deliverables and accountability for consistency of process and approach across clinical study teams within programs.
• Lead and facilitate strategic forums, planning, and operations efforts for the function-including objective and goal setting, organizational planning for vendor visits, lab leadership, and cross-functional business reviews for assigned program(s).
• Support functional laboratory strategy and allocation, translational meetings, IVDR committee workflows, budget management for the program(s), liaising with cross-functional leadership and finance, and review key metrics and Key Performance Indicators to track progress and drive action plans to address issues.
• Build trusted relationships with internal and cross-functional partners and senior leadership-including Precision Medicine Clinical Lab Study Management, Precision Medicine Strategy Leads, and Global Development-and communicate program direction to internal teams, providing frequent executive summaries while remaining able to dive into detail when required.
• Bridge laboratory clinical trial operations across research, translational medicine teams and tech centers at Regeneron, managing timelines for lab delivery in clinical trials and other human-sample projects to ensure seamless execution and adherence to commitments.
• Drive decision making and lead program direction, delivery, and implementation of strategic change and continuous-improvement initiatives for Precision Medicine Operations; including but not limited to samples/assays within the protocols, timeline management for operations, translational medicine initiatives. Incorporate industry best practices and innovation to keep operations current and practical.
This role requires:
• Bachelor's degree and 10+ years of relevant industry experience, preferably in a pharmaceutical or biotech environment or in academic or governmental cross-disciplinary teams.
• Experience with working alongside clinical trials-with a focus on continuous improvement and clinical laboratory operations decision making and alignment.
• Demonstrated process improvement and experience in strategic planning, vendor strategy and governance, risk mitigation, leading internal and external meetings, and complex operational solutioning is essential.
#PMLabOps
Salary Range (annually)
$114,800.00 - $187,400.00
